1. Chabanuk, Arlene J. MSN, RN, CDE

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Q: I have heard there is a new U-200 insulin. What can you tell me about it?


Diabetes mellitus often requires increasing doses of insulin as the disease progresses, even if the patient is exemplary in self-management. Disease progression, changes in the patient's weight, stress, and eating habits can all necessitate a change in insulin dose. With the currently available U-100 insulin, increases in morning short-acting or premeal rapid-acting insulin could result in a large dose requirement of 30 or more units.


In 2015, the U.S. Food and Drug Administration (FDA) approved a new strength of rapid-acting insulin. Approval was based on a demonstration of the bioequivalence of Humalog 200 units/mL relative to Humalog 100 units/mL in a pharmacokinetic/pharmacodynamic study.


Home Healthcare Clinicians (HHC) beware-you can no longer assume your patient is taking U-100 insulin as has been the standard in the United States for many years. U-200 insulin (double the strength/concentration) is now available for treatment of type 1 and 2 diabetes. The FDA has approved the Humalog U-200 KwikPen (insulin lispro 200 U/mL), a prefilled pen that holds twice the amount (600 units vs. 300 units) of rapid-acting insulin as the Humalog U-100 formulation (2015). It is only a matter of time before other manufacturers develop their own U-200/mL rapid-acting insulin brands.


FDA (2015) Dosage and Administration Guidelines for Humalog(R) 200 units/mL:


* Humalog should be given within 15 minutes before or immediately after a meal.


* Do NOT administer Humalog U-200 intravenously.


* Do NOT mix Humalog U-200 in a syringe with any other insulin.


* Do NOT use Humalog U-200 in a subcutaneous insulin infusion pump.


* Do NOT perform dose conversion when using either the Humalog U-100 or Humalog U-200 KwikPens. The dose window shows the number of insulin units to be delivered and no conversion is needed.



Although this new strength of insulin will positively impact the management of blood glucose, especially in the insulin-resistant patient, it will also increase potential for error. For the patient changing from U-100 Humalog to U-200 Humalog insulin, clear oral and written instructions should be provided to the patient/caregiver including:


* When should the patient stop using U-100 Humalog insulin? (Date and Time)


* What should the patient do with the U-100 Humalog insulin in the home at the time of strength change? (Directions for destruction of U-100 Humalog)


* When should the patient start using U-200 Humalog insulin? ( Date, Time, Meal-time dose)



It is critical the HHC performs accurate medication reconciliation at the start of care, after a physician visit or urgent/emergent care visit, and when resuming services after an interim hospitalization. Medication reconciliation now requires close attention not only to type and dose of insulin but also the strength. Failure to do so would result in an inaccurate reconciliation, subsequent incorrect medication orders on the plan of care, and in turn impact the accuracy of patient/caregiver education.


Be sure to confirm the strength and dose of insulin with the patient's primary care provider. Patients/caregivers will need to understand the importance of checking the strength of Humalog when they fill the prescription. This simple safety step may prevent over or under dosing of Humalog insulin due to a dispensing and/or administration error.


The primary side effect of U-200 insulin is hypoglycemia; therefore, it is essential the HHC assures the patient/caregiver is safe in transitioning to this insulin and is knowledgeable in independent self-care management using U-200 insulin.